Earlier this year, we published a deep dive into Terran Biosciences’ apparent intellectual property strategy. We concluded by asking a question:
One might also ask why Terran would repeatedly wade into crowded waters, targeting compounds that are subject to existing IP claims (in some cases, from multiple parties) and found in the pipelines of other companies. In many cases, if Terran sought to develop and commercialise the candidates claimed in its own IP portfolio, it would need to hope that others’ doors were open, too.
Terran, which had been very quiet on its strategy until that point, has now begun publicly sharing its own narrative around strategy.
Perhaps most notably it has done so via an hour-long talk and Q&A at Wonderland Miami (one of multiple appearances that Terran’s CEO, Sam Clark, made in the conference’s agenda) and a press release dated December 8th.
In his Wonderland presentation, Clark shared that his company has developed ‘the world’s first psilocybin salt’, which he said ‘enables Terran and our collaborators to [pursue the] 505(b)(2) pathway … 5 years after psilocybin is approved’. This strategy was reiterated in the aforementioned press release, which announced the grant of four patents, two of which cover psilocybin Hcl and edisylate.
“Terran plans to use its new forms of psilocybin to pursue a rapid 505(b)(2) FDA approval pathway if one of the existing forms of psilocybin currently in clinical trials is approved”, the press release explained.
(A 505(b)(2) New Drug Application (NDA) allows an applicant to rely on studies conducted by a third-party, regardless of whether that party lends permission to do so. As such, it effectively allows an applicant to request approval for a substantially similar drug product without repeating the drug development process from scratch. The applicant must demonstrate similarity to the approved drug product.)
In his talk, Clark mentioned that his company’s discovery of three new psilocybin salts ‘gets around the idea of monopolising all of the polymorphs’. Here, he’s clearly referring to Compass Pathways’ granted patents covering some forms of psilocybin, though it’s not clear that Compass’ IP strategy relies on a total monopolisation of psilocybin polymorphs.
Clark and Terran are keen to position themselves as “moving quickly toward the goal of providing patients with affordable and accessible psilocybin treatment options”. However, it’s not yet possible to be sure of the company’s motive. As we explained in our deep dive, Terran has repeatedly filed patents on certain forms of other companies’ drug candidates, very soon after they came to light.
Take Delix’s tabernanthalog, for example. The compound was generated by David Olson’s lab at UC Davis and is under development by Olson’s drug development company, Delix Therapeutics. However, as we described in our analysis, Terran has sought to claim various forms and methods of using tabernanthalog in its own patent filings.
As announced in the aforementioned press release, Terran has received a notice of allowance for a patent covering a “novel form of tabernanthalog monofumarate and the method of use for treating neurological and psychiatric disorders.”
Is Terran’s primary motivation to provide patients with affordable and accessible treatment options by busting potential ‘monopolies’ after their respective data exclusivity elapses? Or, is it looking to piggyback others’ innovation and generate revenue by licensing out its IP to the highest bidder? Only time will tell.